IGUS: Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT01360658

Collaborator

Ministry of Health, France (Other), Saint-Louis Hospital, Paris, France (Other)

Enrollment

Locations

Arm

Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.

Condition or Disease	Intervention/Treatment	Phase
Solar Urticaria	Drug: Intravenous immunoglobulins	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous immunoglobulins Intravenous immunoglobulins	Drug: Intravenous immunoglobulins Single administration of 2 g/kg intravenous immunoglobulins over 2 days Other Names: CLAIRYG

Arm

Intervention/Treatment

Experimental: Intravenous immunoglobulins

Intravenous immunoglobulins

Drug: Intravenous immunoglobulins

Single administration of 2 g/kg intravenous immunoglobulins over 2 days

Other Names:

CLAIRYG

Outcome Measures

Primary Outcome Measures

Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [3 months]

Secondary Outcome Measures

Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [1 month]
Percentage of patients obtaining 1 month after treatment an improvement of quality of life [1 month]
Percentage of patients obtaining after 1 month of treatment a complete clinical response [1 month]
Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity [1 month]
Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [6 months]
Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [12 months]
Percentage of patients obtaining 3 months after treatment an improvement of quality of life [3 months]
Percentage of patients obtaining 6 months after treatment an improvement of quality of life [6 months]
Percentage of patients obtaining 12 months after treatment an improvement of quality of life [12 months]
Percentage of patients obtaining after 3 months of treatment a complete clinical response [3 months]
Percentage of patients obtaining after 6 months of treatment a complete clinical response [6 months]
Percentage of patients obtaining after 12 months of treatment a complete clinical response [12 months]
Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity [3 months]
Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity [6 months]
Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

social insurance
signed informed consent
solar urticaria (SU) confirmed with photoexplorations
SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU
SU with altered quality of life
SU resistant to photoprotection
SU resistant to the association of two different antihistaminics during 3 months

Exclusion Criteria:

Pregnancy
Heat triggered urticaria
Contra-indications to IVIG

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Regional University Hospital	Besançon	France	25000
2	University Hospital	Caen	France	14033
3	University Hospital	Grenoble	France	38043
4	Regional University Hospital	Lille	France	59037
5	University hospital	Limoges	France	87042
6	Regional University Hospital	Montpellier	France	34295
7	University Hospital	Nancy	France	54035
8	University Hospital	Nîmes	France	30029
9	Saint louis Hospital	Paris	France	75475
10	University Hospital	Reims	France	51092
11	University Hospital	Rennes	France	35033
12	University Hospital	Toulouse	France	31059

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon
Ministry of Health, France
Saint-Louis Hospital, Paris, France

Investigators

Principal Investigator: François Aubin, Pr, University Hospital of Besançon
Principal Investigator: Manuelle Viguier, Dr, Saint-Louis Hospital, Paris, France